TAG:
lab regulation
Do Regulators Really Protect Patients, Consumers?
IMAGINE, FOR A MOMENT, THAT ONE OF YOUR LOVED ONES had gone to Theranos during the past two years to get lab tests. Assume that your loved one was being tested for significant biomarkers that directly affected the care provided to your family member for significant health issues and that your loved o…
NYSDOH Shuts Hospital Lab In Queens, New York
CEO SUMMARY: When the New York State Department of Health closed the laboratory at 173-bed Peninsula Hospital Center in New York City on February 23, it became national news. State inspectors issued a nine-page list of deficiencies in the lab, including problems that could affect patient …
False Positive STD Tests Get News Coverage in Indy
CEO SUMMARY: After going public with the discovery that it had reported false positive lab test results for Chlamydia to eight female patients, Mid America Clinical Laboratories (MACL) found itself the subject of stories broadcast by a local television news program. The news cove…
Specialty Laboratories’ New CEO Reveals How His Company Is Changing
“You will see a more tightly focused Specialty Labs. We won’t try and do everything, rather we will do what is important for our customers.” —Douglas S. Harrington, M.D CEO SUMMARY: In recent months, several events roiled the market for hos…
California Lab Regulators Are A Tough Bunch
CEO SUMMARY: By law, government regulators cannot comment publicly about the actions they take against the companies they regulate. That’s why the lab industry never learned that other public lab companies operating in California, following inspections by state authorities, were judged …
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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